MAUDE Adverse Event Report: ABBOTT MEDICAL REGENT HEART VALVE WITH FLEX CUFF; HEART-VALVE, MECHANICAL

Catalog Number 17AGFN-756

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Renal Failure (2041)

Event Date 03/25/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Crd_1036 - regent china pmcf.Cn5795 - 185 (r745434701).It was reported that on (b)(6) 2023, a 17mm regent aortic mechanical heart valve was successfully implanted in a patient.On (b)(6) 2023, the patient had acute cardiac and renal failure.On (b)(6) 2023, endotracheal intubation and emergency bedside hemodialysis was performed.At 21:30, the patient's blood pressure rose to 111/67mmhg, heart rate was 119 times/min, oxygen saturation was 100%, urine volume was 300ml within 2 hours, blood gas showed normal ph, lactic acid was 2.9mmol/l, blood glucose was 13.9mmol/l.The patient was successfully resuscitated and was reported to be in stable condition.No additional information was provided.

Manufacturer Narrative

An event of acute cardiac and renal failure was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Event Description

(b)(6) - regent china pmcf.(b)(6).It was reported that on (b)(6) 2023, a 17mm regent aortic mechanical heart valve was successfully implanted in a patient.On (b)(6) 2023, the patient had acute cardiac and renal failure.On (b)(6) 2023, endotracheal intubation and emergency bedside hemodialysis was performed.At 21:30, the patient's blood pressure rose to 111/67mmhg, heart rate was 119 times/min, oxygen saturation was 100%, urine volume was 300ml within 2 hours, blood gas showed normal ph, lactic acid was 2.9mmol/l, and blood glucose was 13.9mmol/l.The patient was successfully resuscitated and was reported to be in stable condition.On (b)(6) 2023, the patient was discharged from the hospital.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16740668
• MDR Text Key: 313304948
• Report Number: 2135147-2023-01643
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 17AGFN-756
• Device Lot Number: 7238447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 57 KG